Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan

Exclusion Criteria

• •1. Diagnosed as secondary or hereditary pulmonary alveolar proteinosis
• •2. WBC of 12,000/mm3 or more
• •3. Fever of 38 degree celsius or more
• •4. Severe edema
• •5. History of malignant disease within recent 5 years (not applied to the treated cases of uterine carcinoma in situ and local basal cell carcinoma)
• •6. Complication of cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc with severe condition.
• •7. Complication of respiratory diseases such as pulmonary infectious disease(incl. pulmonary tuberculosis), bronchial asthma, lung fibrosis ,interstitial pneumonitis, or bronchiectasis, in which the evaluations of safety and efficacy of GM-CSF therapy are considered as difficult.
• •8. History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
• •9. Treatment with other cytokines
• •10. Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
• •11. Patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, or rituximab within 6 months before the start of the study (this criterion does not apply to patients for whom 6 months or more have elapsed after their last lavage or rituximab)
• •12. Severe liver dysfunction (AST \> 100 IU/L and/or ALT \> 100 IU/L and/or T-bil \>3.0mg/dL)
• •13. Severe renal dysfunction (Ccr \< 30 mL/min, calculated by Cockcroft-Gault (CG) formula)
• •14. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product
• •15. Treatment with oral or intravenous administration or inhalation of corticosteroids.
• •16. Treatment with other inhaled drugs.
• •17. Previously treated with GM-CSF before the start of the study.
• •18. Demonstrate hypersensitivity to GM-CSF agent.
• •19. Other patients judged to be inappropriate for the study by the attending physician (e.g., patients who are unlikely to complete treatment or are uncooperative).